Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT02640105
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2015-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cluster Headache, Addictions and Vascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003027', 'term': 'Cluster Headache'}], 'ancestors': [{'id': 'D051303', 'term': 'Trigeminal Autonomic Cephalalgias'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2016-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-30', 'studyFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2015-12-21', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of active periods of cluster headache', 'timeFrame': 'Day 0 (Inclusion visit)'}, {'measure': 'Number of active periods', 'timeFrame': 'Day 0 (Inclusion visit)'}, {'measure': 'Duration of cluster headache', 'timeFrame': 'Day 0 (Inclusion visit)'}, {'measure': 'Severity of attacks', 'timeFrame': 'Day 0 (Inclusion visit)'}, {'measure': 'Duration of active periods of cluster headache', 'timeFrame': 'one year after inclusion'}, {'measure': 'Number of active periods', 'timeFrame': 'one year after inclusion'}, {'measure': 'Duration of cluster headache', 'timeFrame': 'one year after inclusion'}, {'measure': 'Severity of attacks', 'timeFrame': 'one year after inclusion'}], 'secondaryOutcomes': [{'measure': 'Existence of an addiction', 'timeFrame': 'Day 0 (Inclusion visit)'}, {'measure': 'Existence of an addiction', 'timeFrame': 'One year after inclusion'}, {'measure': 'Severity of Addiction', 'timeFrame': 'Day 0 (Inclusion visit)'}, {'measure': 'Severity of Addiction', 'timeFrame': 'One year after inclusion'}, {'measure': 'Reactive Hyperemic Index (RHI)', 'timeFrame': 'Day 0 (Inclusion visit)', 'description': 'Endothelial function measurement'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cluster Headache']}, 'descriptionModule': {'briefSummary': 'Cluster headache (CH) is one of the most painful primitive headaches. Developments in neuroimaging have demonstrated activation of the ipsilateral hypothalamic and orexinergic system, which is similar in patients with addictions. CH has strong links to the vascular system but there is no study measuring endothelial function in CH sufferers.', 'detailedDescription': 'Several studies have shown an association between Cluster headache (CH) and smoking. However, no data exists on the link between CH and other addictions, and impact of these addictions on clinical characteristics of the disease. In addition, despite the strong biological link between CH and the vascular system, systematic investigations about vascular functions in CH patients are lacking.\n\nThis will be a prospective cohort study of 150 patients with CH, conducted in the Headache Center in Bordeaux, France.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with cluster headache', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting a chronic or episodic cluster headache diagnosed according to the International Classification of Headache Disorders (ICH-D III) criteria, in active or inactive phase.\n\nExclusion Criteria:\n\n* Other primary headaches\n* Subjects without social insurance'}, 'identificationModule': {'nctId': 'NCT02640105', 'acronym': 'CHAD', 'briefTitle': 'Cluster Headache, Addictions and Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Cluster Headache (CH), Addictions and Vascular Function', 'orgStudyIdInfo': {'id': 'CHUBX 2013/14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with Cluster headache', 'description': 'Prospective follow-up of patient with Cluster headache', 'interventionNames': ['Other: Neurological clinical examination', 'Other: Psychological clinical examination', 'Other: Questionnaires', 'Other: Blood sample', 'Other: Endothelial function measurement']}], 'interventions': [{'name': 'Neurological clinical examination', 'type': 'OTHER', 'description': 'Diagnostic and description of cluster headache', 'armGroupLabels': ['Patient with Cluster headache']}, {'name': 'Psychological clinical examination', 'type': 'OTHER', 'description': 'Scale and questionnaires', 'armGroupLabels': ['Patient with Cluster headache']}, {'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Psychopathological and cognitive questionnaires', 'armGroupLabels': ['Patient with Cluster headache']}, {'name': 'Blood sample', 'type': 'OTHER', 'description': 'Blood sample for DNA collection', 'armGroupLabels': ['Patient with Cluster headache']}, {'name': 'Endothelial function measurement', 'type': 'OTHER', 'description': 'Endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device', 'armGroupLabels': ['Patient with Cluster headache']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}